Appendix A Special Requirements - NQA · IMPACT ON AS9100 ©2008 NQA USA All rights reserved 3/30/2009 •Translate Special Requirements into Critical Items and Key ... Appendix A

APPENDIX AA

SPECIAL REQUIREMENTS

REQUIREMENTS

3/30/2009©2008 NQA USA All rights reserved

All requirements are not created equal

REQUIREMENTS

All requirements are not created equalFailure of some requirements will have greater impactimpactSome requirements will require additional attention and oversightgSome requirements will not easily tolerate variance

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REQUIREMENTS FLOWDOWN


REQUIREMENTS FLOWDOWNMission Requirements Must All Be Met But Are They All Equal In Significance?Mission

• Mission Requirements• Functional Objectives• Mission Environments

R

CSI Non CSI• System Requirements

• CSI – Critical Safety ItemII

R Ry q

• Sub-System Req’ts• User Needs

R R

III

• Component Req’ts

• Part Requirements

R R

3

Criticality Determined By:•Risk Analysis•FMEA•Etc.

INTERRELATED CONCEPTS


New and old terms that are interrelated

INTERRELATED CONCEPTS

Special RequirementsSpecial requirements will be identified when determining

i t l t d t th d t requirements related to the product

Critical ItemsSpecial requirements may then require the identification of critical p q y qitemsDesign output will then include identification of critical items that will require specific actions to ensure they are adequately managed.q p y q y g

Key characteristicsSome critical items will be further classified as key characteristicsV i ti d t b l l it d d t ll dVariation needs to be closely monitored and controlled.

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SIMPLIFIED??


Key Characteristics Simplified

SIMPLIFIED??

y pCommunication of criticality between Engineering & ProductionIn House or Outsourced Production

Special Requirement & Critical items simplifiedCommunication of criticality between Engineering<>Engineering

both in house and outsourcesbot ouse a d outsou ces

Common ExpectationsMore rigorous controls to be in placeg p

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3 2 SPECIAL REQUIREMENTS


Require inclusion into the risk management

3.2 SPECIAL REQUIREMENTS

Require inclusion into the risk management process

high risks to being achieved high risks to being achieved identified either internally or externally

Factors used in determination may include Factors used in determination may include product or process complexity or maturity

Example: Performance requirements imposed by the customer Example: Performance requirements imposed by the customer that are at the limit of the state-of-the-art, or requirements determined by the organization to be at the limit of their technical or process capabilities.

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3 3 CRITICAL ITEMS


Items

3.3 CRITICAL ITEMS

* Hardware * Software* Functions *Parts* Characteristics * Processes

Have significant effect on product realization and use of the product* Safety * Performance* F fi f i * P d ibili * Form, fit, function * Producibility, * Service life

Example: Include safety and flight critical items fracture Example: Include safety and flight critical items, fracture critical items, mission critical items

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RELATIONSHIPS


RELATIONSHIPS7.2.2 Review of requirements related to the

product 7.3.3.e

C iti l itDrawings

Plans

7.5 Production & service provision

Other Requirements

Customer Requirements

Requirements determined as special by the organization

itself

7.3.2 Design inputs

7.3.3 Design outputs

Critical items PlansInstructions

Etc.

7.5.1 .. Control plans for …7.5.1. … verification of

7.5.1.2 … control, & record of changes

7.3.3.e Key characteristics

7.4.2Vendor/Supplier

Requirements flagged as

special by the customer

7.2.2.eSpecial

Requirements

7.1.2Risk Management process

OtherOther Requirements

Customer Requirements

Accepted Product

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Requirements flagged as

special by the customer

EVALUATE IMPLEMENTATION


Has the concepts of special requirements and critical items

EVALUATE IMPLEMENTATION

been integrated in the QMS with key characteristics 7.1 Planning NOTE …requirements for the product include consideration of aspects such as…7.2.2 Review of requirements …d) contractual requirements are reviewed so that special requirements of the product are determined, and e) risks (e.g., new technology, short delivery time frame) have been identified7.3.1 Design… safety and functional objectives of the product in accordance with customer, statutory and regulatory requirements. 7.5.1 Control of Production…− establishing, implementing and maintaining appropriate processes to manage critical items including process controls appropriate processes to manage critical items, including process controls where key characteristics have been identified,…8.2.4 Monitoring and measurement… When critical items, including key characteristics, have been identified the organization shall ensure they are g ycontrolled and monitored in accordance with the established processes.

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IMPACT ON AS9100


IMPACT ON AS9100

•Translate Special Requirements into Critical Items and Key Characteristics

O ti l O ti th t N d Ri kOperational Options that Need Risk Oriented Decisions associated with Special Requirements•Design Approach•V&V ApproachMonitor & Insp Approach

Identification of Special Requirements

Product

•Monitor & Insp. Approach•Supplier Oversight

Proposal Contract Design Manufact. ProductDeliveryIntegrate

Monitoring and Inspection Activities

RFQ

Purchasing

g pCommunication of Supplier Requirements-Key Characteristics-

10All Requirements are not created equal

Suppliers

APPLIED THEORY


Aviation Defense Space

S S S

APPLIED THEORY

Special Requirements Special Requirements Special Requirements

From these identified Special Requirements list some possible associated Critical Items and Key Characteristics.

•Engine that produces in excess of 2 pounds of thrust for every pound of weight and 25% less fuel consumption•Emergency Egress from passenger compartment of commercial passenger jet must be15 minutes or less.New cargo jet must be able to land and take off from smaller•New cargo jet must be able to land and take off from smaller

general aviation airports

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APPLIED THEORY



S S S

APPLIED THEORY



•An armored personnel carrier that will exceed 55 mph in off road conditions with a range of 200+ miles.•A shipboard search radar system that can simultaneously track over 200 individual targets.A 9mm light weight infantry weapon with a rate of fire between 200•A 9mm light weight infantry weapon with a rate of fire between 200

and 300 rounds per minute when automatic fire is selected.

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APPLIED THEORY



S S S

APPLIED THEORY



• An auxiliary solid fuel booster to be used by both the Delta and Atlas missile.•Onboard universal navigation software to be used for interplanetary exploration on both manned and unmanned platforms.A high reliability positioning motor for use on the new constellation•A high reliability positioning motor for use on the new constellation

program.

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OBSTACLES TO IMPLEMENTATION


Developing and integrating the Essential item

OBSTACLES TO IMPLEMENTATION

Developing and integrating the Essential item lifecycle

Understanding all aspects of internal and externalUnderstanding all aspects of internal and external special requirementsUnderstanding how the Risk Concept influencesUnderstanding how the Risk Concept influences the identification of special requirements which translate to critical items and key characteristicsFinding effective ways to communicate special requirements critical items and key characteristics throughout the organization and to Suppliersthroughout the organization and to SuppliersOthers?

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Documents

Appendix A Special Requirements - NQA · IMPACT ON AS9100 ©2008 NQA USA All rights reserved 3/30/2009 •Translate Special Requirements into Critical Items and Key ... Appendix A